False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
For life sciences companies, Brazil’s market offers both an abundance of business opportunities and a myriad of on-the-ground regulatory compliance challenges for new entrants. Getting the market-entry strategy right will...more
Commercial transactions often involve parties from different states. When a dispute arises between diverse parties, the question of whether a party can obtain personal jurisdiction over a defendant becomes critical. This...more
The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more
Securities Class Action Against Swiss-Based Company Dismissed On Forum Non Conveniens Grounds; Second Circuit Finds Strong Inference of “Conscious Recklessness” In Allegations And Reverses Dismissal of Securities Suit Against...more
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
Since 2011, the U.S. Supreme Court has continued to roll back the expansion of personal jurisdiction by lower courts and has set more limitations on where a plaintiff can sue corporate defendants. We have watched this unfold...more
Last week, in In re Vitamin C Antitrust Litigation, the US Court of Appeals for the Second Circuit (“Second Circuit”) vacated a $147 million jury award against Chinese vitamin C sellers Hebei Welcome Pharmaceutical Co. and...more
The California Supreme Court’s recent opinion on specific jurisdiction may have far-reaching consequences for future actions brought in the state. In the recently published opinion in Bristol-Myers Squibb Co. v. Superior...more
Wolters Kluwer had the opportunity this past week to sit down with Pepper Hamilton LLP partners Todd Reinstein, Washington, D.C., and Joan Arnold, Philadelphia, to discuss current tax issues particularly relevant to the life...more
In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more
As Congress Seeks Additional Funding, Inversion Proposal Emerges - Throughout the past several weeks, Pfizer’s attempt to acquire AstraZeneca has garnered significant congressional and media attention. Pfizer, a U.S....more
The fact that GlaxoSmithKline (GSK) has been on China’s radar for bribery is nothing new – the Chinese authorities instituted an investigation against the company in July 2013. What is new is that GSK’s former Vice President...more
Do the intentions behind enforcement of domestic or international anti-corruption laws matter? Or is ‘the law the law’ and it really does not matter what a government’s motives are in enforcing laws that it has on the books....more